Emergency Procedures & Response Flashcards

A clinical trial participant becomes incapacitated mid-study and can no longer provide ongoing consent. The investigator should:

Answer: Obtain consent from a legally authorized representative and reassess continued participation

When a participant loses capacity, a legally authorized representative must be engaged to provide proxy consent before study procedures continue.

An investigator discovers a protocol deviation occurred during an emergency—study drug was given outside the dosing window to stabilize a participant. This should be:

Answer: Documented and reported to the IRB and sponsor per protocol deviation procedures

All protocol deviations, including those made for emergency medical reasons, must be documented and reported to both the IRB and sponsor.

Which regulatory pathway allows emergency use of an unapproved drug outside of a clinical trial when no alternatives exist?

Answer: Expanded access (compassionate use) under 21 CFR 312.310

21 CFR 312.310 governs individual patient expanded access (compassionate use) for emergency situations where no alternatives are available.

A study participant is hospitalized for an SAE. The investigator's source document responsibilities include:

Answer: Hospital records, lab results, and a narrative linking the event to study participation

Complete source documentation for SAEs includes all medical records, lab data, and a narrative account regardless of causality assessment.

During a clinical trial, a participant suffers a stroke. The investigator assesses causality as 'unlikely related' to study drug. This assessment:

Answer: Does not affect the reporting obligation; all SAEs must be reported to the sponsor

All serious adverse events must be reported to the sponsor regardless of the investigator's causality assessment; the sponsor then makes relatedness determinations for FDA reporting.

An emergency protocol amendment is submitted to the IRB to allow a new rescue medication. Under which condition may the investigator implement the amendment before IRB approval?

Answer: When immediate use is necessary to eliminate apparent immediate hazard to participants

Under 21 CFR 56.108(a)(4), investigators may implement unapproved changes when necessary to eliminate an apparent immediate hazard, followed by prompt IRB notification.

A clinical site's emergency contact list for participants should include all of the following EXCEPT:

Answer: Participant's personal financial advisor

Emergency contact materials for participants include medical contacts (investigator, sponsor medical monitor, emergency services) but not personal financial advisors.